QUALITY CHOICE ANTIFUNGAL- tolnaftate ointment

Quality Choice Antifungal by

Drug Labeling and Warnings

Quality Choice Antifungal by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Tolnaftate 1%............................................................Antifungal

PURPOSE

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevent most athlete's foot with daily use
• for effective relief of itching, burning and cracking

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

WHEN USING

When using this product, avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if

• ​irritation occurs
• there is no improvement within 4 weeks

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68°-77°F)

INACTIVE INGREDIENT

Inactive ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

DOSAGE & ADMINISTRATION

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE ANTIFUNGAL 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARETH-20 (UNII: L0Q8IK9E08)
ETHYLPARABEN (UNII: 14255EXE39)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM SULFITE (UNII: VTK01UQK3G)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-529-28	1 in 1 CARTON	07/05/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/05/2019

Labeler - Chain Drug Marketing Association Inc. (011920774)